Dimension LOCI High Sensitivity Troponin I recall
Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac…
Why was Dimension LOCI High Sensitivity Troponin I recalled?
Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # EB0255 UDI: 00842768037726EB025520091110471068840
- Product
- Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 533 US and 1822 OUS
- Distribution
- US Nationwide distribution.
- Recall date
- October 14, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)